The goal of this clinical research study is to find the highest tolerable dose of the combination of Grifola frondosa extract, azacitidine, and lenalidomide that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.

Azacitidine 75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle. Lenalidomide starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.

Drug: Azacitidine

75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.

Other Names:

5-Azacytidine

5-aza

Vidaza

5-AZC

AZA-CR

Ladakamycin

NSC-102816

Drug: Lenalidomide

Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.

Other Names:

CC-5013

Revlimid

Experimental: Azacitidine + Lenalidomide + Grifola Frondosa

Once Lenalidomide MTD identified in combination with azacitidine, Grifola frondosa added. Cycle 1, azacitidine on day 1, lenalidomide on day 2 and Grifola frondosa on day 3. Azacitidine daily for 5 days every 28 days while lenalidomide and Grifola frondosa on days 1-21 of subsequent cycles.

Drug: Azacitidine

75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.

Other Names:

5-Azacytidine

5-aza

Vidaza

5-AZC

AZA-CR

Ladakamycin

NSC-102816

Drug: Lenalidomide

Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.

Other Names:

CC-5013

Revlimid

Drug: Grifola Frondosa

3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.

Experimental: Expansion Group A

Azacitidine + Lenalidomide MTD, then 2 weeks later Grifola frondosa

Drug: Lenalidomide

Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.

Other Names:

CC-5013

Revlimid

Experimental: Expansion Group B

Azacitidine + Grifola Frondosa, then 2 weeks later Lenalidomide

Drug: Lenalidomide

Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.

Patients must be able to understand and be willing to sign an IRB-approved written informed consent document.

Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).

Patients must be 18 years of age or older since the safety and dosages of these study drugs has not been demonstrated in the pediatric population. Exception: patients who are 13 years old or older and have more than 50 kg of body weight will be eligible after consultation with their pediatric attending.

Life expectancy greater than 3 months based on the attending physician's discretion.

All study participants must be registered in the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.

Patients that have had any treatment specific for tumor control within 3 weeks of study drug treatment or: a. within 2 weeks if cytotoxic agents were given weekly b. within 6 weeks for nitrosoureas or mitomycin C c. within 4 half-lives for targeted agents with half lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents) d. failed to recover from toxic effects of any therapy prior to study entry

Subjects with known moderate or severe renal impairment will be excluded if creatinine clearance < 60 ml/min.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200004